Narcotic Use After Minor Hand Surgery

November 18, 2016 updated by: Cassandra Mierisch, Carilion Clinic
This study evaluates the effect of larger or smaller opioid prescriptions following minor surgery on the amount of narcotic used, patient reported satisfaction, refill requests, and leftover narcotic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive prescriptions for either 10 or 30 tabs of 5 mg hydrocodone/325 mg acetaminophen following minor hand surgery. Patients are allowed to request additional medication as needed. Patients are contacted by phone 10-14 days after their surgery to answer a questionnaire regarding number of pills taken, number of refills requested, number of remaining pills, their satisfaction with their pain control and their surgery, and their opinion regarding the appropriateness of the prescription size.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing minor hand surgery by a participating surgeon within the study period

Exclusion Criteria:

  • narcotic use within previous 3 months
  • concurrent procedure
  • acute trauma
  • pregnancy
  • allergy or other contraindication or intolerance to hydrocodone or acetaminophen
  • post-operative complications
  • inability to provide personal consent to the procedure or the research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 group
Initial prescription for 10 narcotic tabs
Behavioral: Initial prescription for 10 narcotic tabs
Reduced number of pills in initial prescription post-operatively
Active Comparator: 30 group
Initial prescription for 30 narcotic tabs
Behavioral: Inital prescription for 30 narcotic tabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic used
Time Frame: 10-14 days post-op
number of narcotic tabs taken by patient (5mg hydrocodone/325 mg acetaminophen)
10-14 days post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of refills requested
Time Frame: 10-14 days post-op
number of times patient requested additional pain medication
10-14 days post-op
Number of left over tabs
Time Frame: 10-14 days post-op
Number of left over usable narcotic tabs remaining in patient possession
10-14 days post-op
Patient reported efficacy of pain control
Time Frame: 10-14 days post-op
10-14 days post-op
Patient reported satisfaction with pain control
Time Frame: 10-14 days post-op
10-14 days post-op
Patient reported satisfaction with overall surgical experience
Time Frame: 10-14 days post-op
10-14 days post-op
Patient Opinion Regarding Appropriateness of Size of Initial Prescription
Time Frame: 10-14 days post-op
10-14 days post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Investigators

  • Principal Investigator: Cassandra Mierisch, MD, Carilion Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 18, 2016

First Posted (Estimate)

November 22, 2016

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMR-CT-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

none currently

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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